Transducer Care and Operator Safety

Observe the following warnings when using disinfectants. More specific warnings and cautions are included within the care and cleaning procedures and on the labels of the cleaning or disinfection solutions.

WARNINGS

Disinfectants are recommended because of their chemical compatibility with product materials, not their biological effectiveness. For the biological effectiveness of a disinfectant, see the guidelines and recommendations of the disinfectant manufacturer, the U.S. Food and Drug Administration, and the U.S. Centers for Disease Control.

The level of disinfection required for a device is dictated by the type of tissue it will contact during use and the type of transducer being used. Ensure that the disinfectant type is appropriate for the type of transducer and the transducer application. For information on the levels of disinfection requirements, see Choosing the Correct Transducer Care Method. Also, see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control, the U.S. Food and Drug Administration, and the U.S. Centers for Disease Control.

Sterile transducer covers with sterile ultrasound transmission gel are required for intraoperative and biopsy procedures. Protective covers are recommended for transrectal and intravaginal procedures; in China and Japan, the covers are mandatory. Philips recommends the use of qualified covers.

In intraoperative applications (other than TEE or endoscopy), transducers used with sterile gel and sterile transducer covers may use either the high-level disinfection or sterilization care method.

Latex Product Alert

Philips ultrasound systems and transducers do not contain natural rubber latex that contacts humans. Natural rubber latex is not used on any ultrasound transducer, including transthoracic, intraoperative, and transesophageal echocardiography (TEE) transducers. It also is not used on Philips ECG cables for the products in this manual.

WARNINGS

Transducer covers can contain natural rubber latex, which may cause allergic reactions in some individuals.

March 29, 1991, Allergic Reactions to Latex-Containing Medical Devices Because of reports of severe allergic reactions to medical devices containing latex (natural rubber), the FDA is advising health care professionals to identify their latex sensitive patients and be prepared to treat allergic reactions promptly. Patient reactions to latex have ranged from contact urticaria to systemic anaphylaxis.

Latex is a component of many medical devices, including surgical and examination gloves, catheters, intubation tubes, anesthesia masks, and dental dams.

Reports to the FDA of allergic reactions to latex-containing medical devices have increased lately. One brand of latex cuffed enema tips was recently recalled after several patients died as a result of anaphylactoid reactions during barium enema procedures. More reports of latex sensitivity have also been found in the medical literature. Repeated exposure to latex both in medical devices and in other consumer products may be part of the reason that the prevalence of latex sensitivity appears to be increasing. For example, it has been reported that 6% to 7% of surgical personnel and 18% to 40% of spina bifida patients are latex sensitive.

Proteins in the latex itself appear to be the primary source of the allergic reactions. Although it is not now known how much protein is likely to cause severe reactions, the FDA is working with manufacturers of latex-containing medical devices to make protein levels in their products as low as possible.

FDA’s recommendations to health professionals in regard to this problem are as follows:

When taking general histories of patients, include questions about latex sensitivity. For surgical and radiology patients, spina bifida patients and health care workers, this recommendation is especially important. Questions about itching, rash or wheezing after wearing latex gloves or inflating a toy balloon may be useful. Patients with positive histories should have their charts flagged.

If latex sensitivity is suspected, consider using devices made with alternative materials, such as plastic. For example, a health professional could wear a non-latex glove over the latex glove if the patient is sensitive. If both the health professional and the patient are sensitive, a latex middle glove could be used. (Latex gloves labeled “Hypoallergenic” may not always prevent adverse reactions.)

Whenever latex-containing medical devices are used, especially when the latex comes in contact with mucous membranes, be alert to the possibility of an allergic reaction.

If an allergic reaction does occur and latex is suspected, advise the patient of a possible latex sensitivity and consider an immunologic evaluation.

Advise the patient to tell health professionals and emergency personnel about any known latex sensitivity before undergoing medical procedures. Consider advising patients with severe latex sensitivity to wear a medical identification bracelet.

The FDA is asking health professionals to report incidents of adverse reactions to latex or other materials used in medical devices. (See the October 1990 FDA Drug Bulletin.) To report an incident, contact the FDA Problem Reporting Program, MedWatch, at 1-800-332-1088, or on the Internet: www.fda.gov/Safety/MedWatch/ For a single copy of a reference list on latex sensitivity, write to: LATEX, FDA, HFZ-220, Rockville, MD 20857.

Transmissible Spongiform Encephalopathy

WARNING

If a sterile transducer cover becomes compromised during an intraoperative application involving a patient with transmissible spongiform encephalopathy, such as Creutzfeldt-Jakob disease, follow the guidelines of the U.S. Centers for Disease Control and this document from the World Health Organization: WHO/CDS/ APH/2000/3, WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies. The transducers for your system cannot be decontaminated using a heat process.

Infection Control

Issues related to infection control affect the operator and the patient. Follow the infection control procedures established in your facility for the protection of both the staff and the patient.

Handling Contaminated Transducers

The primary area of concern is the handling of transducers that have contacted infected patients. Always wear gloves when you handle transducers used in TEE, endocavity, intraoperative, and biopsy procedures that have not been previously disinfected.

For information on cleaning and disinfecting transducers, see Transducer Care.

Removing Blood and Infectious Material from the System

CAUTION Do not wipe the transducer housing joint, strain relief, or cable with isopropyl alcohol. Isopropyl alcohol can damage these parts of the transducer. This damage is not covered by the warranty or your service contract.

Use a gauze pad moistened with soap and water to remove blood on the system and the transducer connectors and cables. Then dry the equipment with a soft cloth to prevent corrosion. You can use a 70% solution of isopropyl alcohol on the system and only on certain parts of some transducers.

Additional cleaning agents are available for transducers. For more information, see Transducer Care. For more information about removing blood and other infectious material from the system, see Disinfecting System Surfaces.

Disposable Drape

If you believe contamination of the system might occur during an exam, Philips recommends that you take universal precautions and cover the system with a disposable drape. Consult your facility's rules regarding equipment use in the presence of infectious disease.

CAUTION

Position the disposable drape so that it does not block the vents on the system, the monitors, or the peripherals.

Transducer Covers

To prevent contamination by blood-borne pathogens, sterile transducer covers are required for intraoperative and biopsy procedures; in China, sterile covers are also required for transrectal, intravaginal, and transesophageal procedures. Protective covers are recommended for transrectal, intravaginal, and transesophageal procedures; the protective covers are mandatory in China and Japan. Philips recommends the use of qualified covers. For procedures for using transducer covers, see the instructions provided with the covers.

WARNINGS

* Latex and talc are commonly used in sheaths marketed to help with infection control in transesophageal, endocavity, and intraoperative imaging applications and during biopsies. Examine the packaging to confirm latex and talc content. Studies have shown that patients can experience allergic reactions with natural rubber latex. See the FDA Medical Alert, March 29, 1991, reprinted in FDA Medical Alert on Latex.

* In intraoperative applications, sterilized transducers should be used with sterile gel and a sterile transducer cover.

* Do not apply the transducer cover until you are ready to perform the procedure.

* Inspect transducer covers before and after use.

* If the sterile transducer cover becomes compromised during an intraoperative application involving a patient with Creutzfeldt-Jakob disease, follow the recommendations described in Transmissible Spongiform Encephalopathy (above).

* Transducer covers are disposable and must not be reused.

* If an installed transducer cover is cut or contaminated before use, the probe should be cleaned and disinfected or sterilized, and a new sterile cover installed.

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